MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number	328519
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that one syringe 1.0ml 31g 6mm s/c u-100 relion broke at the cannula during use.The following was reported by the initial reporter: "it was reported the customer found needles with burrs on them,, needle bent and needle broke during use.Verbatim: consumer husband reported found needles with burrs on them.Most all from first bag in this box.Consumers husband reported 1 needle from this box bent when injecting consumer husband reported 1 needle broke when removing from injection site (stomach) denied reuse of needles".
Event or Problem Description
It was reported that one syringe 1.0ml 31g 6mm s/c u-100 relion broke at the cannula during use.The following was reported by the initial reporter: "it was reported the customer found needles with burrs on them,, needle bent and needle broke during use.Verbatim: consumer husband reported found needles with burrs on them.Most all from first bag in this box.Consumers husband reported 1 needle from this box bent when injecting consumer husband reported 1 needle broke when removing from injection site (stomach) denied reuse of needles".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-11-18.Investigation summary: customer returned (30) 1cc, 6mm, 31g relion syringes in a sealed poly bags from lot # 8351676.Customer states that they found needles with burrs on them.All returned syringes were tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All observations fall within specifications.Customer states that the needle broke during use.All returned syringes were examined and no bent or broken cannula was observed.A review of the device history record was completed for batch # 8351676.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200798522] noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10860355
• Report Number: 1920898-2020-01584
• Device Sequence Number: 3228050
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 8351676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1